NL-OMON51238招募中不适用
Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7® Acetabular System with Vivacit-E® and Longevity® Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation - G7 acetabular system with Highly Crosslinked Polyethylene (HXLPE) inlay
Zimmer-Biomet0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patient must be a legal adult who has reached full skeletal maturity;
- •- Patient must be treated for one of the following indications;
- •o Noninflammatory degenerative joint disease including osteoarthritis and
- •avascular necrosis;
- •o Rheumatoid arthritis;
- •o Correction of functional deformity;
- •o Treatment of non-union, femoral neck fracture and trochanteric fractures of
- •the proximal femur with head involvement, unmanageable by other techniques;
- •o Revision procedures where other treatment or devices have failed
- •- Patient must be able and willing to complete the protocol required follow-up
- •- Patient must be able and willing to sign the IRB/EC approved informed
排除标准
- •- Patient presents with osteoporosis, which in the opinion of the Principal
- •Investigator, may limit the subject*s ability to support total hip arthroplasty
- •using the study device;
- •- Patient has a metabolic disorder that may impair bone formation;
- •- Patient has osteomalacia;
- •- Patient has distant foci of infections which may spread to the implant site
- •or patient with infection, sepsis or osteomyelitis;
- •- Patient has rapid joint destruction, marked bone loss or bone resorption
- •apparent on roentgenogram;
- •- Patient has a vascular insufficiency, muscular atrophy, or neuromuscular
- •- Patient is a current alcohol or drug abuser;
- •- Uncooperative patient or patient with neurologic disorders who is incapable
- •or unwilling to follow directions;
- •- Patient is pregnant.
研究者
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